NORCURON 4mg powder for injection ampoule

Summary of Product characteristics

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RA 8720 AU S4 (REF 4.0) A140814 V3
PRODUCT INFORMATION
NORCURON
®
_(vecuronium bromide) _
NAME OF THE MEDICINE
- Non-proprietary Name:
Vecuronium bromide
- Laboratory Code:
Org NC 45
- Molecular Structure:
_Mol. Formula: C_
_34_
_H_
_57_
_BrN_
_2_
_O_
_4_
_ _
_ _
_ _
_ _
_ _
_Mol. Weight: 637.73 _
_ _
_CHEMICAL NAME: _
_1-[3_

_,17_

_-diacetoxy-2_

_-(piperidin-1-yl)-5_

_-androstan-16_

_-yl] _
_-1-methylpiperidinium bromide _
DESCRIPTION
Vecuronium bromide is a monoquaternary steroid derivative homologous
with pancuronium
bromide.
It is an odourless, bitter tasting white to creamy white,
microcrystalline powder. At 25
o
C (pH
3), its solubility is 16 mg/mL, and pKa is 8.97. Because vecuronium
bromide hydrolyses
rapidly in water, a ready-for-use aqueous solution form is not
available.
Following reconstitution with solvent (Water for Injections) the
resultant solution is isotonic
and has a pH of 4. Norcuron is available in ampoules and vials
containing 4 mg and 10 mg
of vecuronium bromide, respectively. Each ampoule or vial also
contains citric acid, sodium
phosphate, sodium hydroxide and/or phosphoric acid to buffer and
adjust the pH and
mannitol to make isotonic.
PHARMACOLOGY
PHARMACODYNAMICS
Norcuron is a nondepolarising neuromuscular blocking agent possessing
all of the
characteristic pharmacological actions of this class of drugs
(curariform). It acts by
competing for cholinergic receptors at the motor end-plate. The
antagonism to acetylcholine
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RA 8720 AU S4 (REF 4.0) A140814 V3
is inhibited and neuromuscular block is reversed by
acetylcholinesterase inhibitors such as
neostigmine, edrophonium and pyridostigmine. The neuromuscular block
can also be
reversed by sugammadex, a Selective Relaxant Binding Agent. The
potency of Norcuron is
equal to or somewhat greater than that of pancuronium; the duration of
neuromuscular
blockade produced by Norcuron is significantly shorter than that of
pancuronium at initially
equipotent doses with less cumulative effect. The time to onset of
paralysis dec
                                
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